Pelvic Floor Support After Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial Comparing Vaginal Cuff Closure Techniques

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2020-12-30

Brief Summary

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The purpose of this study is to learn about the effect of different vaginal cuff closure techniques on pelvic support after laparoscopic hysterectomy and robotic assisted laparoscopic hysterectomy for benign gynecologic conditions.

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Detailed Description

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Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Laparoscopic - Vaginal Cuff Closure

Group Type ACTIVE_COMPARATOR

Laparoscopic - Vaginal Cuff Closure

Intervention Type PROCEDURE

All participants are scheduled for either laparoscopic or robotic assisted total hysterectomy. At the end of the hysterectomy the vaginal cuff is closed. In this arm the vaginal cuff will be close laparoscopically using an 0-Barbed suture.

Vaginal - Vaginal Cuff Closure

Group Type ACTIVE_COMPARATOR

Vaginal- Vaginal Cuff Closure

Intervention Type PROCEDURE

All participants are scheduled for either laparoscopic or robotic assisted total hysterectomy. At the end of the hysterectomy the vaginal cuff is closed. In this arm the vaginal cuff will be close vaginally using an 0-Vicryl suture in a vertical fashion.

Interventions

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Laparoscopic - Vaginal Cuff Closure

All participants are scheduled for either laparoscopic or robotic assisted total hysterectomy. At the end of the hysterectomy the vaginal cuff is closed. In this arm the vaginal cuff will be close laparoscopically using an 0-Barbed suture.

Intervention Type PROCEDURE

Vaginal- Vaginal Cuff Closure

All participants are scheduled for either laparoscopic or robotic assisted total hysterectomy. At the end of the hysterectomy the vaginal cuff is closed. In this arm the vaginal cuff will be close vaginally using an 0-Vicryl suture in a vertical fashion.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women over 18 years of age undergoing total laparoscopic hysterectomy and robotic assisted total laparoscopic hysterectomy for benign disease.
* Subjects must be able to self-consent.
* Department of Defense beneficiary

Exclusion Criteria

* Patients will be excluded if they undergo a concurrent procedure for prolapse.
* If the indication for the procedure is a malignancy.
* Those that plan to leave the area in less than 1 year will not be included.
* Pop-Q Point C of \>-4

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No